Once-weekly drug Bydureon approved for Type 2 diabetes

The number of diagnosed cases of diabetes in the U.S. nearly tripled between 1989 and 2009.

Treating Type 2 diabetes isn’t easy. It’s not unusual for patients to rely on a variety of drugs over time to manage their blood sugar levels, and many people are forced to self-administer insulin or other injectable drugs, sometimes multiple times per day.

But soon some patients will have another option.

Bydureon, approved by the Federal Drug Administration on Jan. 27, is an injectable drug that, used in conjunction with exercise, a regulated diet and, in some cases, other medications, can help control blood sugar levels for those with Type 2 diabetes through once-weekly injections. The new drug from San Diego-based Amylin Pharmaceuticals Inc. is a modified version of its twice-daily injectable Bayetta and will be available to consumers in February.

With 8.3 percent of the U.S. population suffering from diabetes, the potential for Bydureon’s success is great. Analyst Thomas Russo of Robert W. Baird & Co. said he expects sales to come in around $100 million in 2012.

If Bydureon’s market segment continues to grow, Russo said, that number could end up between $2.5 billion and $3 billion despite competition from Novo Nordisk A/S’ Victoza, a once-daily drug in Bydureon’s category that features a smaller needle. Victoza also fared better in head-to-head tests for blood sugar control.

“For a segment that size, there’s room for more than one product,” Russo said. “It’s going to be somewhat of a tossup between the better and more convenient delivery system of Victoza versus the more convenient once-weekly option with more complex, less desirable product presentation of Bydureon.”

According to the American Diabetes Association, there are 25.8 million people in the U.S. currently living with diabetes with another 79 million people at high risk for developing the disease. Risk of Type 2 diabetes, the most common form of the disease, rises with increasing body weight, and prevalence of Type 2 diabetes is several times higher within the population of obese people.

Hope Warshaw, author of “Real Life Guide to Diabetes,” says the diabetes community feels that Bydureon has the potential to be “what people call a game-changer.”

“I think it will be way easier for people,” Warshaw said. “I think people will still consider an injection a hurdle, but certainly an injection once a week is an easier sell than an injection once a day, than an injection twice a day.”

Pete Wade, a Chicago resident and Type 2 diabetes patient, said he has never thought about using injectable drugs.

“I really wouldn’t want to every day, but for once a week I maybe would consider it. I don’t want to be sticking myself – I don’t even like doing the test every day.”

Research suggests that many feel the way Wade does.

According Dr. Elbert Huang, director for the Center for Translational and Policy Research of Chronic Diseases, there are major problems with patients diligently following the complex diabetes treatment regimen.

“At least a fifth of patients have very poorly controlled blood sugar,” said Huang, who is also an associate professor of medicine at the University of Chicago. “From clinical practice, we know that it’s very likely due to the patient resistance to using medication. They think it’s a tremendous burden, and it turns out that it’s almost entirely due to the idea of injections.”

But while less frequent injections may be attractive to some patients, Huang warned that switching to a once-weekly dose could introduce other potential problems.

“If you have a drug you take daily, it has a different pattern in your life than a drug you take weekly,” he said. “You’re going to have to remember that weekly injection…it’s not an error-free way of taking medication. It could actually cause a different form of non-adherence.”